De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy

Korábbi kezelés

• Any serious systemic infectious disease during four weeks prior to screening, as judged by the Investigator.
• A positive result in the alcohol and/or urine drug screen at the screening visit
• Have received chronic (lasting >14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the past 3 months, or have received any non-topical glucocorticoid therapy within 30 days before screening

Más betegség

• Any history or presence of cancer, except for a history of basal cell skin cancer or squamous cell skin cancer (as judged by the Investigator)
• Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator.
• Signs of acute illness as judged by the Investigator
• Systolic blood pressure < 90 mmHg or >160 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
• Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
• History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months
• Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (for males), 12 grams alcohol/day (for females) on average
• Tested positive for Hepatitis Bs antigen
• Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal, and a hepatitis C polymerase chain reaction is negative)
• Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen

Laborértékek

• Aspartate transaminase (AST) and/or Alanine transaminase (ALT) > 2 times the upper limit of normal
• Estimated glomerular filtration rate (eGFR)<60 mL/min

Egyéb

• Receipt of any medicinal product in clinical development within 60 days or 5 half-lives (if known) of the medicinal product before randomisation in this trial

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
• Subject with type 1 diabetes for at least 3 years
• One or more palpable lipohypertrophy lesions in the abdominal area, the largest of which has a minimum size of 3.0 cm and a maximum size of 12.0 cm (longest axis) as confirmed by ultrasound.
• Treated with multiple daily injections (≥3) of insulin for at least 2 years or continuous subcutaneous insulin infusion for at least 1 year.
• Subject is willing and able to continue same basal insulin during trial participation.
• Body Mass Index (BMI) 18.5 to 30.0 kg/m², inclusive
• HbA1c at screening between 6.5% and 9.5% (inclusive)
• Have clinical laboratory test results within the normal range for the population, or with abnormalities deemed clinically insignificant by the investigator.
• Considered generally healthy (apart from type 1 diabetes and lipohypertrophy) upon completion of medical history and screening safety assessments, as judged by the Investigator
• Have venous access sufficient to allow cannulation for blood sampling as required by the protocol